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    Summary
    EudraCT Number:2013-003390-95
    Sponsor's Protocol Code Number:WN28745
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003390-95
    A.3Full title of the trial
    A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety study of Gantenerumab in patients with Mild Alzheimer?s disease
    ENSAYO FASE III, RANDOMIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, EN GRUPOS PARALELOS, MULTICÉNTRICO, PARA VALORAR LA EFICACIA Y SEGURIDAD DE GANTENERUMAB EN PACIENTES CON ENFERMEDAD DE ALZHEIMER LEVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Gantenerumab in Patients with Mild Alzheimer Disease
    Estudio de Gantenerumab en pacientes con Enfermedad de Alzheimer Leve
    A.4.1Sponsor's protocol code numberWN28745
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoche Farma S.A en nombre de F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGantenerumab
    D.3.2Product code Ro 490-9832/F12
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgantenerumab
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeRO4909832
    D.3.9.3Other descriptive namehuman anti-A? antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typerecombinant human monoclonal antibody anticuerpo humano monoclonal recombinante
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGantenerumab
    D.3.2Product code Ro 490-9832/F14
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgantenerumab
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeRO4909832
    D.3.9.3Other descriptive namehuman anti-A? antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typerecombinant human monoclonal antibody anticuerpo humano monoclonal recombinante
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MILD ALZHEIMER?S DISEASE
    Enfermedad de Alzheimer Leve
    E.1.1.1Medical condition in easily understood language
    MILD ALZHEIMER?S DISEASE
    Enfermedad de Alzheimer Leve
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the efficacy of gantenerumab compared with placebo administered to patients by SC injection over 100 weeks as measured by the following co-primary endpoints (final outcome assessment 4 weeks after the final dose):
    ? Cognition measured by the Alzheimer?s Disease Activity Scale?Cognitive (ADAS-Cog) (13-item)
    ? Function assessed by the Alzheimer?s Disease Cooperative Study?Activities of Daily Living (ADCS-ADL)
    Evaluar la eficacia de gantenerumab comparado con placebo, administrado a los pacientes en inyección subcutánea (SC) durante 100 semanas, que se determinará basándose en las covariables principales siguientes (la evaluación del resultado final se realizará 4 semanas después de administrar la última dosis):
    ? Capacidad cognitiva, valorada mediante la Alzheimer?s Disease Activity Scale?Cognitive (ADAS-Cog) (13 ítems)
    ? Capacidad funcional, valorada mediante el Alzheimer?s Disease Cooperative Study?Activities of Daily Living (ADCS-ADL)
    E.2.2Secondary objectives of the trial
    1. to evaluate the benefits of gantenerumab versus placebo administered to patients by SC injection over 100 weeks on slowing clinical decline and disease progression by assessing the following:
    ? Time to clinically evident decline
    ? Disease pathology biomarkers
    2. Additional secondary endpoints
    · Global: Effect on severity of dementia and global measures of cognition and function
    · Cognition: Effect on cognition
    · Behavioar: Effect on behavioral and neuropsychological symptoms of AD
    · Other AD symptoms and effects: Effect of gantenerumab on health-related QoL, patient-individualized goal achievement (sites in English- and French-speaking countries only), on caregiver emotional well-being, on the amount of assistance patients with dementia require in performing daily activities
    Evaluar beneficios de gantenerumab frente a placebo, administrado a pacientes en inyección SC durante 100 semanas, respecto a retraso de deterioro clínico y la progresión de la enfermedad.Se valorará en base:
    Tiempo hasta deterioro clínicamente evidente
    Biomarcadores de patología de la enfermedad
    Objetivos secundarios adicionales:
    Medidas globales-Efecto sobre severidad de demencia y medidas globales de capacidad cognitiva y funcional.
    Capacidad cognitiva-Efecto sobre capacidad cognitiva
    Síntomas conductuales-Efecto sobre síntomas conductuales y neuropsicológicos de EA
    Otros síntomas y efectos relacionados con EA: Efecto de gantenerumab sobre calidad de vida relacionada con salud (CVRS), consecución de objetivos individualizados de pacientes (se aplicará sólo en centros de países de habla inglesa y francesa), sobre bienestar emocional del cuidador, sobre cantidad de ayuda que requieren los pacientes con demencia para realizar las actividades diarias
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    WN28745-PET Substudy, version 1, dated 19-Nov-2013

    Title: PET IMAGING SUBSTUDY ASSOCIATED WITH: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH MILD ALZHEIMER?S DISEASE

    The primary objective of the WN28745-PET substudy is to assess changes in amyloid load over time using florbetapir in patients enrolled in Study WN28745 who are treated with gantenerumab (RO4909832) or placebo. This patient population has probable mild AD (based on NINCDS/ADRDA criteria) or probable major NCD due to AD of mild severity (based on the DSM-5 criteria)

    The secondary objective of this substudy is to assess the concordance between positivity or negativity on CSF A?1?42 testing at entry in Study WN28745 and amyloid PET visual read in the WN28745-PET substudy.
    E.3Principal inclusion criteria
    - Adult patients, 50 to 90 years of age, inclusive
    - Clinical diagnosis of probable mild Alzheimer disease based on NINCDS/ADRDA criteria
    - Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the patient, and is able to provide accurate information regarding the patient's cognitive and functional abilities
    - Fluency in the language of the tests used at the study site
    - Willingness and ability to complete all aspects of the study
    - Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
    - If currently receiving approved medications for AD, doses must have been stable for at least 5 months prior to randomization
    ?Tener entre 50 y 90 años de edad, ambos inclusive
    ?Diagnóstico clínico de EA leve probable, basándose en los criterios NINCDS/ADRDA
    ?Contar con una persona (?cuidador?) que, de acuerdo con el criterio del investigador, mantenga un contacto frecuente y suficiente con el paciente, y sea capaz de proporcionar información exacta con respecto a las capacidades cognitivas y funcionales del paciente.
    ?Dominar el idioma de los test utilizados en el centro del estudio
    ?Disposición y capacidad para completar todos los aspectos del estudio
    ?Agudeza visual y auditiva suficiente (está permitido el uso de gafas graduadas y audífonos) para realizar los test neuropsicológicos, de acuerdo con el criterio del investigador
    ?En el momento de la inclusión en el estudio, estará permitido el uso de medicaciones para la EA aprobadas siempre que los pacientes estén recibiendo una dosis y una pauta posológica estable 5 meses antes de la randomización.
    E.4Principal exclusion criteria
    - Dementia or NCD due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
    - History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
    - History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
    - History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
    - History of schizophrenia, schizoaffective disorder, or bipolar disorder
    - Alcohol and/or substance abuse or dependence (according to the DSM-5) within the past 2 years (nicotine use is allowed)
    - History or presence of atrial fibrillation
    - Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
    - Uncontrolled hypertension
    - Chronic kidney disease
    - Impaired hepatic function
    - Demencia o NCD debidos a trastornos distintos de la EA, incluyendo, aunque no exclusivamente, demencia frontotemporal, enfermedad de Parkinson, demencia con cuerpos de Lewy, enfermedad de Huntington o demencia vascular
    - Antecedentes o presencia de enfermedades vasculares clínicamente evidentes que afecten potencialmente al cerebro que, en opinión del investigador, tengan el potencial de afectar a la capacidad cognitiva
    - Antecedentes o presencia de ictus en los 2 últimos años o antecedentes documentados de ataque isquémico transitorio en los 12 últimos meses
    - Antecedentes o presencia de trastornos autoinmunes sistémicos que causen potencialmente enfermedad neurológica progresiva asociada a déficits cognitivos
    - Antecedentes de esquizofrenia, trastornos esquizoafectivos o trastornos bipolares
    - Abuso o dependencia de alcohol y/o sustancias tóxicas (de acuerdo con DSM-5) en los 2 últimos años (está permitido el uso de nicotina)
    - Antecedentes o presencia de fibrilación auricular
    - Enfermedades cardiovasculares inestables o clínicamente significativas en los 2 últimos años
    - Hipertensión no controlada
    - Enfermedad renal crónica
    - Deterioro de la función hepática
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in Alzheimer's Disease Activity Scale-Cognitive subscale 13 (ADAS-Cog13) scores

    Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores
    Cambio medio con respecto al valor basal en la puntuación ADAS Cog13

    Cambio medio con respecto al valor basal en la puntuación ADCS-ADL
    E.5.1.1Timepoint(s) of evaluation of this end point
    - from baseline to Week 104
    - desde el período basal hasta la semana 104
    E.5.2Secondary end point(s)
    - Change in biomarkers (t-tau, p-tau, Abeta 1-42 levels) in cerebral spinal fluid
    - Change in MRI volumetry, assessed on structural MRI
    - Change in Clinical Dementia Rating (CDR-SB/CDR-GS)
    - Change in neuropsychiatric behaviour: Neuropsychiatric Inventory (NPI) total and domain scores
    - Change in cognition: MMSE total score
    - Safety: Incidence of adverse events, serious adverse events and treatment discontinuations
    - Cambio en biomarcadores en el LCR, en las concentraciones de t-tau, p-tau y Abeta1-42
    - Cambio en la volumetría en RM, evaluada en una RM estructural
    - Cambio en CDR-SB/CDR-GS
    - Cambio en la conducta neuropsiquiátrica: Puntuación total y de los dominios del NPI
    - Cambio en la función cognitiva: Puntuación total del MMSE
    - Seguridad: Incidencia de acontecimientos adversos, de acontecimientos adversos graves y de suspensión del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - from baseline to Week 104
    - from baseline to Week 104
    - from baseline to Week 104
    - from baseline to Week 104
    - from baseline to Week 104
    - 152 weeks
    - desde el período basal hasta la semana 104
    - desde el período basal hasta la semana 104
    - desde el período basal hasta la semana 104
    - desde el período basal hasta la semana 104
    - desde el período basal hasta la semana 104
    - 152 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers, exploratory biomarkers, clinical genotyping, imaging.
    Biomarcadores, biomarcadores exploratorios, genotipos clínicos, imágenes.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Guatemala
    Hungary
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date when the last patient, last visit (LPLV) occurs
    or the date on which the last datapoint required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.
    La terminación del estudio se define como la fecha en la que tiene lugar la última visita del último paciente (UVUP) o la fecha en la que se reciben los últimos datos del último paciente requeridos para el análisis estadístico o para el seguimiento de la seguridad, dependiendo de la que sea posterior.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 900
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 357
    F.4.2.2In the whole clinical trial 1000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Currently, the Sponsor does not have any plans to provide gantenerumab to patients after conclusion of the study or any earlier patient withdrawal. The Sponsor will evaluate the appropriateness of continuing to provide gantenerumab to study patients based on emerging data, which may include an interim analysis of Study WN28745. If the data are medically and statistically significant, the Sponsor may amend the protocol to continue to provide the drug in an open-label extension study to patients.
    Actualmnt, el promotor (P) no tiene planeado suministrar gantenerumab a pacientes (pte) tras la conclusión del estudio o abandono prematuro de algún pte. El P evaluará continuar con el suministro de gantenerumab en estudios de ptes. basados en datos emergentes, que pueden incluir análisis intermedio del studioWN28745. Si datos son medicamente y estadísticamente significativos, P puede realizar enmienda protocolo para continuar suministro de medicación a ptes. en estudio abierto de ampliación.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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